Contenu en anglais !

Date: 20 September 2023 

Companion diagnostics (also known as CDx) is a particular category of IVD devices, used to aid in the assessment of patients for whom a specific drug therapy is being considered. The IVDR has increased requirements for CDx.  Most CDx devices are now in risk Class C and require Notified Body oversight for placement on the market.

In addition, a Notified Body is required to consult the competent authority designated by the member states in accordance with Directive 2001/83/EC or the European Medicines Agency (EMA) as applicable, which results in a longer approval process.

What is the webinar about?

This webinar will update attendees on the latest BSI knowledge and best practise with regards to IVDR Companion Diagnostic conformity assessment. This will include:

• Classification
• Technical Documentation best practise
• Performance Evaluation best practise and common pitfalls
• EMA consultation process

Who should attend?

This webinar will be of particular interest to manufacturers of companion diagnostic devices. It will also offer notified body insights for all people involved in working towards an IVDR application, whether you are a novice or have experience of working with a notified body.

What will participants gain?

Join this in-depth extended webinar to hear subject matter experts, Liz Harrison, Global Head of IVD, and Elizabeth Linch, Technical Specialist & Scheme Manager, share their knowledge, hints and tips on how to navigate CDx conformity assessment with Notified Bodies and EMA. You will also gain a better understanding of the status related to high-risk CDx.

Dr Elizabeth Harrison is BSI's Global Head of In Vitro Diagnostics. She is responsible for operational delivery of technical documentation review and certificate decisions for IVDD, IVDR and UKCA.

Before joining BSI in 2014, she held senior and principle scientist roles in design and development of NAT diagnostic platforms for near-patient testing of sepsis, respiratory infections, genetic disease, cancer and companion diagnostics.

She also spent time as a post-doctoral scientist in the School of Translational Medicine at the University of Manchester investigating rapid diagnostics for sepsis and respiratory disease. Liz holds a BSc (Hons) in Biochemistry and a PhD in molecular diagnostics.

Elizabeth is a Technical Specialist and Scheme Manager at BSI, leveraging five years of expertise in performing conformity assessment under IVDR. Specializing in companion diagnostics, she has navigated the entire conformity assessment process for a companion diagnostic device, including consultation with the medicinal product authority.

Before joining the notified body business, she worked as a scientist, designing and developing large multiplex next-generation sequencing tests intended to be used for human genetic testing and detecting cancer markers, including companion diagnostics.